Early-Onset Myopia Intervention Project

Shanghai Eye Disease Prevention and Treatment Center508 enrolled

Overview

The prevalence of myopia among children has been increasing year by year, which has become a globle public health issue. Studies have shown that defocusing lenses and atroping eyedrops can control the progression of myopia, but there is little evidence of its efficacy in myopia intervention of young pre-schoolers who will face a greater risk of progression to high myopia later in life. Therefore, this study aims to evaluate the effectiveness and safety of spectacle lenses with highly aspherical lenslets (Essilor's Stellest) , as well as 0.01% and 0.05% low concentration atropine eyedrops in myopia intervention among young children aged 3-6.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

508

Conditions

Myopia Pre-myopia

Interventions

Spectacle lenses with highly aspherical lensletsDEVICE

These are a special type of eyeglass lenses designed primarily to slow down the progression of myopia (nearsightedness) in children. The center of the lens provides a clear correction for distance vision, just like regular glasses. The surrounding area contains hundreds of tiny, invisible, and highly aspherical (complex curved) microlenses. These microlenses create a special optical effect. While the child looks straight ahead clearly, peripheral light rays are focused in front of the retina. This is called "myopic defocus." Research suggests that this myopic defocus signal helps to control the excessive elongation of the eyeball, which is the main cause of myopia getting worse.

Eligibility

Sex: ALLMin age: 3 YearsMax age: 6 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age 3-6 years, gender unrestricted; * Bilateral cycloplegic spherical equivalent (SE) ≤ +0.75 D, astigmatism ≤-2.5 D, anisometropia ≤2.5 D; * Best corrected visual acuity: ≥0.5 for ages 3-5, ≥0.7 for age 6; * Accept regular follow-up, written informed consent from guardians, verbal informed consent from children; * Possess normal thinking and language communication skills, and can actively cooperate to wear spectacles as required. Exclusion Criteria: * Existence of strabismus or amblyopia or other binocular vision abnormalities, accommodation dysfunction, cataract and history of eye surgery; * Any ocular or systemic disease that may affect vision and refractive development (e.g., Keratoconus, Marfan syndrome, retinopathy of prematurity, etc.); * Current or previous use of other treatments for myopia intervention, such as pharmacological (atropine) and optical (orthokeratology lenses or DIMS spectacle lenses) approaches, interrupt use for at least 4 weeks; * Allergy or contraindication to cycloplegic drugs; * Epilepsy or other mental disorders unable to expressing consent; * Other conditions deemed unsuitable for participation by the researcher.

Outcomes

Primary Outcomes

Changes in cycloplegic spherical equivalence

Measured by an auto-refractometer

Time frame: 2 year

Secondary Outcomes

Changes in axial length

Measured by an IOL-Master

Time frame: 2 years

Proportion of subjects with non-rapid myopia progression

Rapid myopia progression is defined as: spherical equivalence increase (become less positive or more negative refractive error) of any eye ≥ 0.5 D in half a year.

Time frame: 2 years

The duration of non-rapid myopia progression

Rapid myopia progression is defined as: spherical equivalence increase (become less positive or more negative refractive error) of any eye ≥ 0.5 D in half a year.

Time frame: 2 years

Early-Onset Myopia Intervention Project

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts